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NCT Number: NCT05059132

Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study

This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy.

The specific aims and hypotheses are:

Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40).

Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program.

Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events.

Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40).

Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including:

1. accelerometry-measured physical activity (primary outcome); and 2. functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).

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Key information

Conditions

Lung Neoplasm Behavior Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Colorado

Aurora, Colorado, 80014, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • history of stage I-IIIA lung cancer;
  • completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months;
  • access to a mobile phone or personal computer with internet access;
  • willingness to wear activity trackers

Exclusion criteria

  • dementia (or cognitive impairment identified by chart review) resulting in inability to follow directions or provide written informed consent;
  • acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, acute cerebrovascular event, or acute asthma exacerbation in past 2 months;
  • spontaneous pneumothorax in past 12 months;
  • Parkinson's disease;
  • multiple sclerosis;
  • amyotrophic lateral sclerosis;
  • additional movement/gait disorders that may be identified by chart review

Treatment and study plan

Tele-rehabilitation

Behavioral

The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.

Education only

Other

The education only arm will receive information on the importance of general exercise following lung cancer treatment.

Primary outcomes

  1. Difference in change in accelerometry-measured physical activity between baseline and week 12

    Time frame: Baseline, mid study (week 6), and end of study (week 12).

    Physical activity will be measured by the activPAL4 device (PAL Technologies, Ltd).

Secondary outcomes

  1. Difference in change in functional capacity between baseline and week 12

    Time frame: Baseline, mid study (week 6), and end of study (week 12)

    Functional capacity will be measured using the mobile six-minute walk test.

  2. Difference in change in self-reported physical activity between baseline and week 12

    Time frame: Baseline, mid study (week 6), and end of study (week 12)

    Self-reported physical activity will be measured using the International Physical Activity Questionnaire - Short Form

  3. Difference in change in control of dyspnea between baseline and week 12

    Time frame: Baseline, mid study (week 6), and end of study (week 12)

    Dyspnea control will be measured using the the University of California, San Diego Shortness of Breath Questionnaire.

  4. Difference in change in anxiety symptoms between baseline and week 12

    Time frame: Baseline, mid study (week 6), and end of study (week 12)

    Anxiety symptoms will be measured using the General Anxiety Disorder-7

  5. Difference in change in sleep quality between baseline and week 12

    Time frame: Baseline, mid study (week 6), and end of study (week 12)

    Sleep quality will be measured using the Pittsburgh Sleep Quality Index

  6. Difference in change in quality of life between baseline and week 12

    Time frame: Baseline, mid study (week 6), and end of study (week 12)

    Quality of life will be measured using the St. George's Respiratory Questionnaire

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • American Lung Association

Registry information

Official study title

Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 28, 2021
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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